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EU regulator starts real-time review of Merck's COVID-19 pill


The Merck brand is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid

Oct 25 (Reuters) – U.S. drugmaker Merck & Co Inc (MRK.N) stated on Monday the European Union’s drug regulator has initiated a real-time evaluation of its experimental COVID-19 antiviral drug for adults.

Beneath the process, also called a “rolling evaluation”, the European Medicines Company (EMA) would assess information as quickly because it turns into obtainable, as an alternative of ready for a proper utility when all required info has been gathered.

Whereas vaccines are the principle weapons in opposition to COVID-19, Merck’s experimental tablet molnupiravir may very well be a game-changer after research confirmed it might halve the possibilities of dying or being hospitalised for these most liable to contracting extreme sickness.

Merck, which is creating molnupiravir with accomplice Ridgeback Biotherapeutics, filed for U.S. emergency use authorization for the drug on Oct. 11. A panel of outdoor advisers to the U.S. well being regulator at the moment are slated to fulfill late in November to debate whether or not to authorize the experimental antiviral tablet. read more

Molnupiravir if authorized by regulators, can be the primary COVID-19 drug administered orally and likewise the primary remedy for mildly ailing sufferers, whereas current medicine are principally used to deal with the critically in poor health.

The drugmaker has a contract with the U.S. authorities to provide 1.7 million programs of the drug at a worth of $700 per course. It additionally just lately signed provide offers with nations together with Britain, Malaysia and Singapore.

An EU official instructed Reuters earlier within the month that the bloc too was additionally contemplating signing a provide settlement for the antiviral tablet, however would accomplish that solely after the corporate began the method of in search of approval. read more

Reporting by Mrinmay Dey and Shubham Kalia in Bengaluru; Modifying by Saumyadeb Chakrabarty

Our Requirements: The Thomson Reuters Trust Principles.



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